Dry Eye Disease MedDRA version: 20.0 Level: PT Classification code 10013774 Term: Dry eye System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Eye Drops New Platform Unit-dose (EDNP UD)
Product Code: 11002X
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: CARMELLOSE S
Sponsors
Allergan Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, = 18 years of age and in good general health 2. Written informed consent and written documentation in accordance with the relevant country and local privacy requirements have been obtained prior to any study procedures 3. Have used artificial tears for dry eye 4. If using RESTASIS® Cyclosporine Ophthalmic Emulsion, must be using drops for = 6 months prior to day 1 (baseline) 5. Women of childbearing potential with a negative pregnancy test result at day 1 (baseline)and who are currently using a reliable form of birth control and agree to use this birth control for the duration of the study 6. OSDI score of = 18 and = 65 (based upon a 0 to 100 scale) 7. Three consecutive tear break-up time (TBUT) tests of = 10 seconds in at least 1 eye 8. Corneal and/or conjunctival staining of Grade 1 to 4 (Oxford Scheme, score range = 0 to 5) in at least 1 zone that is related to dry eye in at least 1 eye at day 1 (baseline) 9. Any systemic medications (over-the-counter, herbal, prescription or nutritional supplements) which may affect dry eye or vision must have a start date of = 3 months from day 1 (baseline) date and dosage is not expected to change during the study 11. Ability/agreement to continue to wear existing current spectacle correction during the study period (if applicable) 12. Currently corrected distance visual acuity of at least 6/12 Snellen equivalent in each eye using the 3 meter LogMar chart, with current correction (if necessary) 13. Ability to follow study instructions and likely to complete all required visits Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 324 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 81
Exclusion criteria
Exclusion criteria: 1. Uncontrolled systemic disease 2. Known allergy or sensitivity to the study product(s) or its components 3. Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable method of contraception 4. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study at day 1 (baseline) 5. Schirmer test (with anesthesia) = 2 mm in either eye at day 1 (baseline) 6. Anticipated contact lens wear during the study, or subject has worn contact lenses in the last 3 months, prior to day 1 (baseline) 7. Any scheduled or planned ocular or systemic surgery or procedure during the study which in the investigator’s opinion may impact the subject’s study participation 8. Corneal or conjunctival staining grade of 5 (Oxford Scheme, grade range = 0 to 5) at day 1 (baseline) in any one zone of either eye 9. The start date of any systemic medication (including over-the-counter, herbal, prescription, or nutritional supplements) which may affect dry eye or vision is < 3 months prior to day 1 (baseline) or a change in dosage is anticipated during the study 10. Presence of one or more of the following ocular conditions: active ocular infection or non-keratoconjunctivitis sicca (KCS) ocular inflammation • active ocular allergy • history of recurrent herpes keratitis or active disease within 6 months prior to day 1 (baseline) • corneal disorder or abnormality that affects corneal sensitivity or normal spreading of the tear film (except superficial punctuate keratitis) • severe blepharitis or obvious inflammation of the lid margin which in the judgment of the investigator, may interfere with the interpretation of the study results • KCS secondary to the destruction of conjunctival goblet cells such as occurs with vitamin A deficiency or scarring such as that with cicatricial pemphigoid, alkali burns, Stevens-Johnson syndrome, trachoma, or irradiation • substantial non-KCS keratitis with overlying corneal stain or other significant corneal findings not directly related to dry eye. Also, subjects with dry eye signs/symptoms (eg, filamentary keratitis) of a severity where topical monotherapy with an artificial tear would be inappropriate 11. Occlusion of the lacrimal puncta, for either eye, with punctal plugs or cauterization < 3 months prior to day 1 (baseline) 12. History of ocular/ophthalmic surgery or trauma which could affect corneal sensitivity and/or tear distribution (eg, cataract surgery, laser-assisted in situ keratomileusis [LASIK], photorefractive keratectomy or any surgery involving a limbal or corneal incision) within 6 months prior to day 1 (baseline) 13. Subjects cannot enroll if currently using topical ocular medication, or have used topical ocular medication within 2 weeks of enrollment. Exceptions: subjects can be considered who are being bilaterally treated with ONE of the following: • monotherapy for glaucoma or OHT using a prostaglandin analog, beta blocker OR Alpha-2 agonist • RESTASIS Cyclosporine Ophthalmic Emulsion 14. Subjects who have discontinued use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of Eye Drops New Platform Unit-Dose (EDNP UD) in subjects with signs and symptoms of dry eye disease;Secondary Objective: Not applicable; Primary end point(s): Primary Efficacy Measure: • Change from baseline in the Ocular Surface Disease Index© (OSDI) Questionnaire Score Safety Measures: • Adverse Events • Biomicroscopy • Currently Corrected Distance Visual Acuity • Best-corrected Visual Acuity (BCVA) • IOP ;Timepoint(s) of evaluation of this end point: Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Measures: • Tear Break-up Time (TBUT) (with fluorescein) • Corneal staining (Oxford Scheme, with fluorescein) • Conjunctival staining (Oxford Scheme, with lissamine green) • Schirmer test (with anesthesia) ;Timepoint(s) of evaluation of this end point: At visit days 1, 7, 30, 60, 90 or early exit | — |
Countries
Australia, Belgium, France, Germany, Italy, Russian Federation, Spain, United Kingdom
Contacts
Public ContactAllergan Ltd. EU Regulatory Affairs
Allergan Limited
Outcome results
None listed